Category Archives: Enablement

SCOTUS concludes Amgen’s anti-PCSK9 antibody claims not enabled

Posted on May 24, 2023 by Patrick J. Halloran, Ph.D., J.D.

Amgen Inc. v. Sanofi, et al. Docket No. 2020-1074 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.OPINION.2-11-2021_1731739.pdf) PROST, LOURIE, HUGHES November 7, 2022 Update (original decision on February 11, 2021) Fourth Update (May 18, 2023):  SCOTUS concludes Amgen’s specification does not support “’the entire genus’ of antibodies … Continue reading →

Posted in Enablement | Leave a comment

FC panel affirms DC finding that Amgen’s Otezla® composition patents are not invalid, but also that method of treatment claims are invalid, for obviousness

Posted on April 21, 2023 by Patrick J. Halloran, Ph.D., J.D.

Amgen Inc. v. Sandoz Inc. et al. Docket No. 2020-1147, 1149-51 (https://cafc.uscourts.gov/opinions-orders/22-1147.OPINION.4-19-2023_2113208.pdf) LOURIE, CUNNINGHAM, STARK April 19, 2023 Brief Summary:   DC finding that two of Amgen’s Otezla® composition patents not invalid for obviousness affirmed.  DC finding that another of … Continue reading →

Posted in Enablement, Generics / ANDA, Inherency, Method claims, Obviousness, Obviousness (Secondary Considerations), Obviousness-Teaching Away, Priority, Written description | Leave a comment

DC decision of infringement and no invalidity of Pharmacyclic’s BTK inhibitor-related patents affirmed

Posted on November 29, 2022 by Patrick J. Halloran, Ph.D., J.D.

Pharmacyclics LLC, Jannsen Biotech, Inc. v. Alvogen, Inc., Natco Pharma Limited Docket No. 2021-2270 (https://cafc.uscourts.gov/opinions-orders/21-2270.OPINION.11-15-2022_2033497.pdf) (Non-Precedential) CHEN, BRYSON, HUGHES November 15, 2022 Brief Summary:   DC decisions that Pharmacyclic’s patents were infringed and not invalid for lack of written description, … Continue reading →

Posted in Anticipation (35 USC 102), Double Patenting, Enablement, Generics / ANDA, Incorporation by Reference, Infringement, Method claims, Obviousness, Obviousness (Secondary Considerations), Priority, Public Accessibility, Written description | Leave a comment

SCOTUS grants Amgen’s request for certiorari of lack of enablement of its anti-PCSK9 antibody claims; petition for FC en banc hearing previously denied (June 21, 2021)

Posted on November 7, 2022 by Patrick J. Halloran, Ph.D., J.D.

Amgen Inc. v. Sanofi, et al. SCOTUS Docket No. 21-757; FC Docket No. 2020-1074 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.OPINION.2-11-2021_1731739.pdf) PROST, LOURIE, HUGHES November 7, 2022 Update (original FC Panel decision on February 11, 2021) Third Update (November 7, 2022):  SCOTUS granted certiorari regarding the … Continue reading →

Posted in Enablement | Leave a comment

Amgen’s petition for en banc hearing regarding enablement of anti-PCSK9 antibody claims denied

Posted on June 24, 2021 by Patrick J. Halloran, Ph.D., J.D.

Amgen Inc. v. Sanofi, et al. Docket No. 2020-1074 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.OPINION.2-11-2021_1731739.pdf) PROST, LOURIE, HUGHES February 11, 2021 (updated June 21, 2021) Update (June 21, 2021):  Amgen’s petition for rehearing en banc was denied.  Judges Lourie, Prost and Hughes authored an opinion … Continue reading →

Posted in Enablement | Leave a comment

PacBio’s claims not enabled for “full scope of nucleic acids covered”; Oxford’s COVID-related statements not prejudicial

Posted on May 14, 2021 by Patrick J. Halloran, Ph.D., J.D.

Pacific Biosciences of California, Inc. v. Oxford Nanopore Techs., Inc. Docket No. 2020-2155, -2156 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-2155.OPINION.5-11-2021_1776046.pdf) LOURIE, TARANTO, STOLL May 11, 2021 Brief Summary:  Lack of enablement finding affirmed (e.g., “relevant artisans did not know how to perform nanopore sequencing for … Continue reading →

Posted in Enablement | Leave a comment

Obviousness conclusion reversed as prior art was not enabled for claimed invention

Posted on April 21, 2021 by Patrick J. Halloran, Ph.D., J.D.

Raytheon Techs. Corp. v. General Electric Co. (USPTO as Intervenor) Docket No. 2020-1755 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1755.OPINION.4-16-2021_1764430.pdf) LOURIE, CHEN, HUGHES April 16, 2021 Brief Summary:  IPR obviousness decision reversed as prior art was not enabled. Summary:  Raytheon appealed IPR final written decision (FWD) … Continue reading →

Posted in Enablement, Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

FC panel affirms DC claim construction, enablement, damages, and no willfulness findings

Posted on March 9, 2021 by Patrick J. Halloran, Ph.D., J.D.

Bayer Healthcare LLC v. Baxalta Inc. et al. and Nektar Therapeutics Docket No. 2019-2418, 2020-1017 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2418.OPINION.3-1-2021_1740684.pdf) NEWMAN, LINN, STOLL March 1, 2021 Brief Summary:  DC claim construction, enablement, damages, and no willfulness findings affirmed. Summary:  Baxalta/Nektar (“B/N”) appealed DC denial … Continue reading →

Posted in Claim Construction, Damages, Enablement, Royalties, Willfullness | Leave a comment

DC lack of enablement of Amgen’s anti-PCSK9 antibody claims affirmed

Posted on February 12, 2021 by Patrick J. Halloran, Ph.D., J.D.

Amgen Inc. v. Sanofi, et al. Docket No. 2020-1074 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.OPINION.2-11-2021_1731739.pdf) PROST, LOURIE, HUGHES February 11, 2021 Brief Summary:  DC lack of enablement of Amgen’s anti-PCSK9 antibody claims affirmed. Summary:  Amgen appealed DC grant of JMOL for lack of enablement of … Continue reading →

Posted in Enablement | Leave a comment

Injunction, damages, infringement and invalidity decisions regarding Illumina’s fetal testing patents affirmed

Posted on April 28, 2020 by Patrick J. Halloran, Ph.D., J.D.

Verinata Health, Inc., Illumina, Inc. v. Ariosa Diagnostics, Inc., Roche Mol. Sys., Inc. Docket No. 22018-2198, -2303, -2305, -2306, -2317 REYNA, WALLACH, HUGHES April 24, 2020 (Non-precedential) Brief Summary: DC denial of injunction and damages, as well as its refusal … Continue reading →

Posted in Anticipation (35 USC 102), Doctrine of equivalents, Enablement, Infringement, Software | Leave a comment